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Objective: This article presents an updated analysis of the LIGALS register, a prospective study conducted over a ten-year period (2009-2018) in Liguria, Italy, aimed at evaluating the incidence, prevalence, clinical presentation, and management of amyotrophic lateral sclerosis (ALS)., Methods: We calculated the mean annual crude incidence rate of ALS, assessed the point prevalence of ALS on January 1, 2018, and analyzed demographic factors, clinical characteristics, and clinical management strategies. Data analysis included Cox regression analysis to identify predictors of survival., Results: The mean annual crude incidence rate of ALS was 3.16/100,000 per year (CI 95%) while the point prevalence of ALS on January 1, 2018, was 9.31/100,000 population (CI 95%). Among the patients, 6.5% were familial ALS, while 93.5% were sporadic cases. Clinical management strategies, including percutaneous endoscopic gastrostomy (PEG) and noninvasive ventilation (NIV), were employed. The study observed a stable frequency of NIV initiation and PEG placement over time, with a growing trend toward earlier PEG positioning. The mean survival from symptom onset was 39 months, whereas from diagnosis, it was 26 months. Cox regression analysis identified several predictors of survival, including gender, age at onset and diagnosis, site of onset, diagnostic category, phenotype, and diagnostic delay., Conclusions: This comprehensive analysis provides valuable insights into the long-term trends in ALS epidemiology and clinical management in Liguria, Italy. It underscores the importance of continued research efforts in understanding and addressing the challenges posed by ALS, particularly in terms of early diagnosis and optimizing clinical interventions to improve patient outcomes.

The purpose of this paper is to bring attention to the complex issue of conflicts of interest (COIs) from the point of view of Scientific Societies and their responsibility in managing secondary interests possibly undermining their activities such as improvement of professional quality, research promotion, and development of guidelines. The first publication on the issue of COIs dates back to more than a century, but only in the last decades the related ethical and legal problems have received public and professional attention. The growing role of industry in biomedical research, the significant decrease in public contributions to health, care, training, and research, and the involvement of physicians in industry-funded research have obliged to study how to identify and manage COIs. The Bioethics and Palliative Care Study Group of the Italian Neurological Society addressed the issue with a specific focus on Scientific Societies that, in our opinion, should also set an example for individual practice, raising awareness among their associates on COIs and implementing strategies for their identification and management. The paper is focused on the nature of the COI, why and how it could be managed, which policies can be implemented, and which kind of action should be considered by Scientific Societies. We emphasize the role of Scientific Societies in fostering knowledge and awareness of conflicts of interest through training and continuing education.

Background: Allergen-specific immunotherapy (AIT) still remains the only causal treatment for IgE mediated respiratory diseases (rhinitis/asthma) In addition to the observed clinical decrease in symptoms, AIT can provide a long-lasting and preventive effect. In particular it can modify the progression from rhinitis to asthma., Methods: The study was observational, open, non randomized, controlled, prospective and performed in a real-life setting. Patients with pure mite-induced allergic rhinitis were followed-up, receiving adjuvanted SLIT (aSLIT), standard SLIT (sSLIT) or drug treatment alone, according to their preference starting between 2008 and 2009. The possible onset of asthma, changes in pulmonary function and bronchial hyperreactivity (BHR) were assessed over a 5-year horizon. Also the onset of new sensitizations and symptoms-medication score (SMS) were evaluated., Results: One hundred forty two patients fulfilling the inclusion criteria were assessed at baseline, and 124 had the 5-year evaluation (age range 8-57, 69 male). After 5 years of treatment, new sensitizations appeared differentially among treatments with 58.1% of new sensitizations in the drug treatment group, 13.2% in the sSLIT patients, and 8.1% in the aSLIT patients. At the end of 5 years, SMS significantly changed ( P  < 0.001) in all groups, with a negative trend for controls, as compared to the SLIT treatments. The SMS decreased in both SLIT groups at 5 years, with no change in patients on drug treatment alone. The use of salbutamol (absent at baseline), showed an overall increase only in the group receiving drugs alone with a significant difference at 5 years ( P  < 0.001). Considering the MCh challenge, there was a difference among treatments ( P  < 0.001) in PD20 after 5 years: the control group had a lower PD20 at 5 years. No significant difference in PD20 was detected between sSLIT and aSLIT. The FEV1 significantly decreased in controls, with no change in the sSLIT group and a significant increase in aSLIT as compared to sSLIT., Discussion: Despite the limitations inherent to a real-life setting study (absence of randomization and control, small sample size, lack of intermediate timepoint assessment) the results of this study evidenced that the investigated SLIT product, either adjuvanted or not, had a positive effect on the evolution of respiratory allergy due to house dust mite., Conclusion: In the real life setting, considering a 5-year period, aSLIT and sSLIT reduced the onset of new sensistizations and maintained intact the pulmonary function, as compared to patients receiving drug treatment alone.

Background: We evaluated whether obstructive sleep apnoea (OSA) and continuous positive airway pressure (CPAP) treatment influence left ventricular (LV) remodelling independently of abdominal obesity and metabolic syndrome (MetS)., Methods: Cardiorespiratory examination, 24-h BP monitoring and echocardiogram were performed in overweight/obese patients with increased abdominal adiposity and symptoms suggesting OSA : OSA/MetS (n.50), OSA/noMetS (n.22), noOSA/MetS (n.29), noOSA/noMets (n.16). The evaluation was repeated in 41 patients after ≥18 months of CPAP., Results: Despite similar age, gender, BMI and 24-h BP, the 2 groups with MetS had greater LV remodelling (LV hypertrophy and diastolic dysfunction) than the 2 groups without MetS. From multiple regression analysis independent determinants for LV mass were MetS, 24-h systolic BP and age, for LV diastolic function were LV mass index, MetS and age. After CPAP, the 20 patients with decreased body weight showed diastolic BP decrease, LV hypertrophy regression and diastolic function improvement, whereas, despite similar respiratory improvement, BP and LV parameters were unchanged in the 21 patients with body weight unchanged/increased., Conclusion: In patients with increased abdominal adiposity, LV remodelling is not associated to OSA per se; chronic CPAP treatment does not influence LV remodelling whose regression is mainly linked to body weight decrease., (Copyright © 2011 Elsevier Ltd. All rights reserved.)

Background: Data on the long-term effects of sublingual immunotherapy (SLIT) are sparse, and the optimal duration of treatment is a matter of debate., Objective: We sought to prospectively evaluate the long-term effect of SLIT given for 3, 4, or 5 years and to compare the effect of those different durations., Methods: In this prospective open controlled study we followed up patients with respiratory allergy who were monosensitized to mites for 15 years. The subjects were divided in 4 groups receiving drug therapy alone or SLIT for 3, 4, or 5 years. Clinical scores, skin sensitizations, methacholine reactivity, and nasal eosinophil counts were evaluated every year during the winter months. The clinical effect was considered to persist until clinical scores remained at less than 50% of the baseline value, and then patients underwent another course of SLIT., Results: Seventy-eight patients were enrolled, and 59 completed the study. In the 12 control subjects no relevant change in clinical scores was seen throughout the study. In the patients receiving SLIT for 3 years, the clinical benefit persisted for 7 years. In those receiving immunotherapy for 4 or 5 years, the clinical benefit persisted for 8 years. New sensitizations occurred in all the control subjects over 15 years and in less than a quarter of the patients receiving SLIT (21%, 12%, and 11%, respectively). The second course of vaccination induced a benefit more rapidly than the first course. The behavior of bronchial hyperreactivity and nasal eosinophils paralleled the clinical score., Conclusion: Under the present conditions, it can be suggested that a 4-year duration of SLIT is the optimal choice because it induces a long-lasting clinical improvement similar to that seen with a 5-year course and greater than that of a 3-year vaccination., (Copyright © 2010 American Academy of Allergy, Asthma & Immunology. Published by Mosby, Inc. All rights reserved.)

Background: No studies have directly compared the effects of immunotherapy and antileukotrienes due to the long time required to appreciate the clinical effects of immunotherapy. We compared the effect of montelukast (MK) and SLIT added to standard therapy in moderate asthma over 5 years., Methods: Open randomized controlled trial. Patients with moderate asthma (and rhinitis) solely due to birch pollen were randomized to receive either MK (10 mg/d) or birch sublingual immunotherapy (SLIT) in the pollen seasons, in addition to formoterol/fluticasone. All the patients also received salbutamol and cetirizine as rescue medications. Asthma and rhinitis symptoms were recorded on diary cards from February to May at baseline and after 3 and 5 years of study. In-season nasal eosinophils and bronchial hyperresponsiveness were also evaluated., Results: Thirty-three adult patients were enrolled and 29 completed the study. The groups were homogeneous at baseline. Bronchial and nasal symptom scores were lower at 3 and 5 years compared to baseline in the SLIT group. Bronchial hyperresponsiveness and bronchodilator use decreased significantly in both groups at 5 years, but only in the SLIT group at 3 years. In the SLIT group there was a significant decrease in nasal eosinophils compared to baseline and to the MK group., Conclusion: In patients with birch pollen-induced moderate asthma and rhinitis, the addition of SLIT provides a greater clinical benefit than that of MK.

Background: Very few studies have evaluated the effects of sublingual immunotherapy (SLIT) in elderly adults with either rhinitis or bronchial asthma. The aim of this study was to ascertain whether SLIT is effective in these patients., Methods: One hundred and sixty seven patients (aged 18-65 years) with persistent rhinitis and mild asthma, selected from 573 subjects allergic to house-dust mites, were treated with either standard chronic pharmacotherapy or SLIT plus drugs on demand. Monthly symptom/drug scores, respiratory function, methacholine (MCh) challenge and eosinophil count were scheduled at the beginning and end of the study., Results: We analysed two age groups (18-28 years, 49 patients) and 55-65 years, 40 patients). There were no differences between the groups at baseline but MCh sensitivity was lower in the older patients. At the end of treatment, SLIT achieved improvement in all variables (p< 0.001) in both age groups, but the global symptoms were lower in the younger patients (p=0.0002). There were also fewer new sensitizations in the SLIT groups (p=0.03) than in the "control"patients given standard pharmacotherapy, but with no relation to age. Asthma became worse only in the control groups, regardless of age., Conclusions: SLIT reduces symptoms, drug consumption and the progression of the disease in both young and elderly subjects allergic to house-dust mites, with persistent rhinitis and mild bronchial asthma.

Background: Subcutaneous immunotherapy for respiratory allergy has shown a long lasting efficacy after its discontinuation, whereas evidence in the case of sublingual immunotherapy (SLIT) is weak. This retrospective study evaluates whether SLIT exerts a long-lasting effect and whether it relates to its duration., Methods: Sixty-five patients allergic to mite and positive to methacholine challenge 13 years ago were studied. Twelve (control group, SLIT 0) were treated for 4 years only with standard pharmacological therapy (SPT), while 53 received SLIT and SPT. Among these, four groups were identified according to SLIT duration. Fifteen patients were treated for 1 year (SLIT 1), 10 for 2 (SLIT 2), 14 for 3 (SLIT 3) and 14 for 4 years (SLIT 4). Clinical parameters (symptom monthly score, SMS), bronchial reactivity and FEV1 were evaluated in 1992 (run-in), 1993 (baseline) and every 2 years from 1997 to 2005., Results: Two to 3 years after the treatment ended, a positive effect on SMS, but not methacholine challenge and FEV1, was seen in the SLIT groups versus SLIT 0. At this time interval an effect on methacholine challenge was also seen in SLIT 3. After 7-8 years a significant difference was seen for SMS, i.e., it was significantly better in SLIT 4 than in the other groups, while bronchial reactivity was still improved in SLIT 1, 3 and 4 only after 5-6 years., Conclusions: The effects of a 4-year SLIT on clinical parameters but not bronchial reactivity and FEV1 last 7-8 years after its discontinuation. SLIT shorter than 4 years yields proportionally less impressive results., (Copyright 2007 S. Karger AG, Basel.)

Background: Sublingual immunotherapy (SLIT) has been proved effective in allergic rhinitis, but there are few studies assessing its effects on inflammation and on the lower airways., Objective: We sought to evaluate at the same time the effects of SLIT on rhinitis symptoms, nasal inflammation, and lower airways function in patients with birch pollinosis., Methods: Adult patients with rhinitis and asthma monosensitized to birch were evaluated during a run-in pollen season and then randomized to receive openly either drugs alone or drugs plus SLIT and reevaluated in the subsequent 4 pollen seasons. Rhinitis symptoms and consumption of bronchodilators were assessed by means of diary card. A nasal smear for eosinophil count was carried out in and out of pollen seasons, and pulmonary function tests with methacholine challenge were performed at each season., Results: Of 79 enrolled patients, 27 dropped out, with a significantly higher rate of dropouts in the control group. There was a decrease in symptoms and bronchodilator use in the SLIT group versus the control group, becoming significant at the second and third pollen seasons, respectively ( P < .01 at all times). Nasal eosinophils decreased significantly in the active group, starting from the third pollen season ( P < .01). In the SLIT group a significant increase in FEV 1 , specific airways conductance, and maximal expiratory flow at 25% of forced vital capacity was seen starting from the second year and was associated with an increase in the methacholine threshold dose ( P < .01). The differences were significant also at the intragroup comparison over time., Conclusion: SLIT achieved a significant clinical benefit in birch pollinosis, reduced the eosinophil infiltration in nasal mucosa, and significantly improved pulmonary function during the pollen seasons.

Background: Some aspects of allergic progression still need to be addressed. To prevent the onset of the progression is not, at present, a very realistic aim, although therapeutic instruments are available to delay and, if possible, to stop it. We attempted to clarify these points in an observational open controlled three-parallel group study in a real-life setting., Methods: 3838 patients with respiratory allergy due to house dust mite have been enrolled in this observational study. 2200 patients with rhinitis and/or intermittent or mild persistent asthma, poorly responsive to standard pharmacological therapy (SPT) were treated for three years with SPT associated or not with specific immunotherapy (SIT). Symptom medication scores, pulmonary function test (PFT) and methacholine (MCh) challenge were performed at the beginning and at the end of the study. 1638 pure rhinitics, responsive to SPT, enrolled as a control group, used self-medication (SM) on demand to assess the incidence of asthma in non-treated patients with standard therapeutic protocols., Results: 694 patients have been treated with SPT+SIT, 1506 with SPT and 1638 with SM. Co-morbidity rhinitis-asthma incidence was higher in the SM group (an overall 69.27% including asthma and bronchial hyperreactivity). Persistent rhinitis proved more often to be associated with asthma than intermittent rhinitis. Likewise, the moderate-severe forms compared to the mild ones. The addition of SIT to SPT reduced the allergic progression in all patients., Conclusions: In everyday clinical practice too, SIT proves its efficacy in the treatment of allergic march. Patients with moderate-severe persistent rhinitis appear as the ideal candidates for this therapy.

Background: That specific immunotherapy (SIT) can slow the march of allergy has been confirmed in controlled clinical trials. However, an assessment of its effects in everyday life, in a large cohort of patients, might provide further useful information., Methods: This observational study comprised 3,643 patients allergic to pollens; 1,620 with pure allergic rhinitis or rhinitis and intermittent or mild-persistent bronchial asthma, responding poorly to standard pharmacological therapy (SPT), were treated for 3 years with SPT alone (pure rhinitis, n = 890), or combined with continuous SIT (rhinitis and asthma, n = 730). Symptom/drug scores were recorded, respiratory function and skin tests were done, and methacholine challenge was scheduled at the beginning and end of the study. A series of 2,023 patients with pure rhinitis, responsive to SPT, were asked to 'self-medicate' as needed, serving as a control group to check the incidence of asthma., Results: The incidence of rhinitis-asthma co-morbidity was highest in the self-medication group (50.8%). Persistent rhinitis was associated with asthma more often than the intermittent form, regardless of the severity of the symptoms that led to progression to asthma in patients with intermittent rhinitis. Treatment with SIT combined with SPT always slowed the allergic march which, however, was not influenced by drugs alone., Conclusions: In routine clinical practice, SIT is effective in preventing the allergic march. Patients with persistent rhinitis, who are at greatest risk of progression to asthma, appear to be the most logical candidates., (2004 S. Karger AG, Basel.)

The aim of this study was to assess the efficacy and safety of sublingual immunotherapy (SLIT) in a Clinical Practice Improvement (CPI) program carried out in allergology. The study was conducted between 1992 and 2001 using an observational type methodology in line with standard clinical practice. The program consisted of 4 basic steps: setting up of a decision-making tree; standardization of main diagnostic and therapeutic aspects; data collection; definition and evaluation of main clinical endpoints. Study patients were screened among 1508 patients with pollen and/or dust mite respiratory allergy, 350 of which, one year after having experienced a pharmacological treatment failure, were administered immunotherapy by injection (n = 111) or alternative route (n = 239). For each one of the three immunotherapy treatment groups (nasal, SLIT or injective) there was a control group of patients who, despite their poor response to pharmacological treatment, continued with pharmacological therapy alone (n = 314 in total; 68, 192 and 54 respectively). The observation of 130 SLIT patients, 106 of which were treated for at least 36 months, towards the control group evidenced that such therapy, apart from resulting efficient and particularly safe, has an unfailing protective effect against the development of asthma and new allergic sensitizations.